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AAAAI: Pulmicort Respules (Budesonide Inhalation Suspension) Helps Tough-to-Treat Asthmatic Children By Jill Stein Special to DG News NEW YORK, NY -- March 5, 2002 -- Young children with mild to moderate asthma whose disease is poorly controlled on prior therapy experience significant benefit with Pulmicort Respules™ (budesonide inhalation suspension). Results from a retrospective, placebo controlled, integrated analysis of three trials were presented here yesterday at the 58th Annual Meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI). Dr. Stanley Galant, with Clinical Trials of Orange County in Orange, California, and colleagues assessed the efficacy of budesonide inhalation suspension (BIS) compared with placebo in children ranging from six months to eight years of age. Subjects had asthma that was previously treated with either an inhaled corticosteroid or a daily nonsteroidal maintenance medication. Patients were randomized to placebo or BIS administered via nebulizer and compressor qd or bid at dosages of 0.25 to 2.0 mg/day. Patients or their parents/guardians recorded daytime and nighttime asthma symptoms daily on an ordinal scale. Results showed that patients whose asthma symptoms did not respond to prior treatment with another inhaled corticosteroid or maintenance nonsteroidal treatment had symptom improvement with BIS. Patients who did not respond to another inhaled corticosteroid prior to study entry had the greater response to BIS relative to patients in the placebo group. "The absence of a placebo effect in this subgroup underscores the need for an effective anti-inflammatory agent for these children," Dr. Galant said. Budesonide inhalation suspension is the first nebulized corticosteroid formulation available in the United States and the only inhaled corticosteroid to be approved by the US Food and Drug Administration for asthma treatment in children as young as 12 months. The research was funded by AstraZeneca LP. E-mail this page to a friend or colleague! To print, use this version